Patient Safety Associate II / Patient Safety Specialist
About the Role
Company Description
Parexel is a clinical development partner that helps biopharmaceutical companies move new therapies forward. The company offers services that include research, consulting, regulatory support and patient-focused development. With teams that have areas of expertise and operations in many countries Parexel brings together scientific knowledge, technology and the ability to run operations. This helps improve the quality of research and helps get new treatments to patients faster.
Job Description
This job helps with pharmacovigilance operations by handling safety cases making regulatory submissions watching for information from the literature and doing compliance work. The job includes looking at safety information keeping correct safety data helping with ICSR submissions working with other offices and helping with regulatory intelligence. This is a 9-month temporary on-site job mainly in Mohali with Hyderabad also listed as a possible place.
Key Responsibilities
Make sure safety reports from different places are correct.
MedDRA coding, assess how likely something is caused by a drug check if it was expected and write case details.
Ensure the case stories are correct and keep all the safety documents.
Help with ICSR and regular safety reports on time.
Look through the literature to find reactions to medicines and possible safety issues.
Work with offices about the rules for pharmacovigilance in different countries.
Do checks on data, quality checks and other quality assurance work.
Help with intelligence and share new rules and updates.
Help update the safety database for products and do work related to the life cycle.
Work with teams inside the company, clients and others to finish safety jobs on time.
Stay up to date with the safety details of products the rules for labels and the rules for pharmacovigilance around the world.
Help make processes better do reports on metrics keep records and work on operating procedures.
Educational Qualification
Bachelor’s degree in Pharmacy, Nursing, Life Sciences, Health Sciences or another related health field is needed.
Acceptable backgrounds include Pharmacy, Biomedical Sciences, Microbiology, Biochemistry, Biotechnology, Dentistry or similar degrees or work experience.
The job needs 2+ years of experience in handling safety cases reporting rules or in a pharmaceutical or health care setting.
People should know ICH-local pharmacovigilance rules and how clinical trials work.
An advanced degree or a certification in pharmacovigilance or regulatory affairs is better.
Skills Required
Understanding of pharmacovigilance and drug safety processes.
Knowledge of ICSR case handling and reporting rules.
Familiar with MedDRA coding, how to find the cause if it is serious and if it was expected.
Ability to use safety databases and PV systems.
Understanding of ICH-GCP. The rules for safety in different areas of the world.
Good at analyzing and solving problems.
Focus on details and making sure data is correct.
Good at writing and talking clearly.
Good at organizing and managing time.
Ability to handle tasks and meet the rules on time.
Good with MS Office and safety or data analysis tools.
Ability to work well with teams over the world and different groups.
Knowledge of EudraVigilance, eCopy or similar PV systems is a plus.
Salary Structure
At Parexel International, the average salary for a Patient Safety Associate II in India ranges from ₹5.4 Lakhs and ₹6.8 Lakhs per year.
Career Development
This job can help build skills in ICSR processing, submissions watching the literature, safety databases and global pharmacovigilance rules. With experience people can move up to Senior Patient Safety Associate, Patient Safety Specialist, Safety Lead, PV Quality, Regulatory Safety or other Drug Safety management jobs.
How to Apply
Go to our career portal and search for "Patient Safety Associate II / Patient Safety Specialist.”
Open the job posting. Check the rules to see if you are eligible.
Click Apply. Send your updated resume, with the needed details.
Check your application. Then click Submit.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.